Impact of Customized Respiratory Training on Cardiopulmonary Function in Parkison's Disease

The Impact of a Customized Respiratory Muscle Training and Maintenance Program on Cardiopulmonary Function in People With Parkinson's Disease.

People with PD have lower cardiopulmonary function than their age matched peers. This decline can further impair a person's ability to participate in exercise and daily activities.

Furthermore, the limitations in cardiopulmonary function can have a severe impact on mortality. There is evidence indicating the positive changes IMT can have on cardiopulmonary function in people with PD. Through intensive daily exercise people with PD have shown improvements in maximum inspiratory pressure and maximum expiratory pressure though detraining does occur when the intervention is not continued. The purpose of the proposed study is to determine if improvements in expiratory muscle strength can be maintained with a maintenance inspiratory muscle training program. The hypothesis is that there will be a significant change from baseline at the three and six month follow ups.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: inspiratory muscle training

Detailed Description

Testers will complete the following outcome measures at the pretest: height, weight, maximum inspiratory pressure, maximum expiratory pressure, heart rate, blood pressure, respiratory rate, six-minute walk test, and Fatigue Impact Scale in person.17,18 Participants, and caregivers if necessary, will be educated on how to complete the intensive IMT program. The dosage will be IMT 3 times/day for 20 repetitions each with resistance set at 30% of baseline maximum for 12 weeks. This training will occur at home.

Participants will record daily their completion of the intensive IMT. Investigators will contact participants weekly for follow-up of compliance and questions. Participants will be contacted either through email, text, or phone call, depending on their preference.

After 12 weeks of intensive IMT training, the investigators will complete the first posttest which will include the following assessments: maximum inspiratory pressure, maximum expiratory pressure, heart rate, blood pressure, respiratory rate, six-minute walk test, and fatiguability scale in person.

Participants, and caregivers if necessary, will be educated on the maintenance IMT program. The dosage for the maintenance program will be 33% of their intensive IMT program, which will result in IMT 1 time/day for 20 repetitions with resistance set at 30% of baseline maximum at the first posttest. The participants will continue the maintenance program for 12 more weeks.

Participants will record daily their completion of the maintenance IMT program. Investigators will contact participants weekly for follow-up of compliance and questions. Participants will be contacted either through email, text, or phone call, depending on their preference.

After the 12 weeks of maintenance IMT, the investigators will complete the second posttest which will include the following assessments: maximum inspiratory pressure, maximum expiratory pressure, heart rate, blood pressure, respiratory rate, six-minute walk test, and fatiguability scale in person.

The participants will receive a $50 Amazon gift card upon the completion of second posttest. The participants will also be allowed to keep their IMT devices for continued use.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen Barta, DPT, PhD; Phone Number: 737-202-3341; Email: kbarta@usa.edu
• Study Contact Backup: Name: Elizabeth Ardolino, PT, PhD; Phone Number: 737-202-3343; Email: eardolino@usa.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78739
      • Recruiting
      • University of St. Augustine for Health Sciences
      • Contact: Kristen Barta, DPT, PhD; Phone Number: 737-202-3341; Email: kbarta@usa.edu
      • Contact: Germaine Ferreira, DPT; Phone Number: 737-202-3356; Email: gferreira@usa.edu
      • Sub-Investigator: Nicole Borman, PT, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• physician's diagnosis of Parkinson's disease

Exclusion Criteria:

• people who are actively smoking, have a pacemaker, recent diagnosis of chronic obstructive pulmonary disease, bronchial asthma, active pulmonary disease within 1 month, or hospitalization within 2 months of time of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Inspiratory Muscle Training; involves the intervention portion of the study to improve strength of the cardiopulmonary system	Other: inspiratory muscle training; Participants will complete inspiratory muscle training daily in their homes for 12 weeks. The dosage will depend on their initial maximum pressure. At the end of the 12 week intensive period, participants will reduce the inspiratory resistance by a third and continue a maintenance training for an additional 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum expiratory pressure	measure of the maximum expiratory cardiopulmonary pressure	5 minutes
maximum inspiratory pressure	measure of the maximum inspiratory cardiopulmonary pressure	5 minutes
6 minute walk test	distance walked in 6 minutes	8 minutes
Fatigue Impact Scale	measure of a person's self report fatigue, ranges from 0-36 and higher score indicates greater impact of fatigue	10 minutes
heart rate	heart beats per minutes	1 minute
respiratory rate	breaths per minute	1 minute
blood pressure	measure of rest blood pressure	1 minute

Collaborators and Investigators

• Sponsor: University of St. Augustine for Health Sciences
• Investigators: Principal Investigator: Kristen Barta, PT, PhD, The University of St. Augustine for Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PT-0928-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No